Oxycodone User Registry (OUR)

April 1, 2010 updated by: Ortho-McNeil Janssen Scientific Affairs, LLC

A Prospective, Multi-center, Observational Registry of Patients Using Prescription Medications Containing Oxycodone Immediate Release for the Treatment of Pain

The purpose of this study is to describe clinical and demographic characteristics of patients receiving prescription medications containing oxycodone immediate release (OXYRX), to characterize patient and prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment, to describe prescriber decision-making about pain management with a Schedule II opioid and to explore how prescribers identify suspected abuse of pain medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Real-world utility of Schedule II immediate release opioids depends on both efficacy and side effects. Few existing data sources systematically captured opioid-related side effects and their impact on patient outcomes and physician practice. This study is expected to lead to an in-depth understanding of patient and prescriber perceptions of both effectiveness and side effects associated with medications containing the most widely prescribed oral Schedule II immediate release opioid for pain management, oxycodone immediate release (OXYRX), alone (eg, Roxicodone®) or in combination (eg, Percocet®, Tylox®) in actual clinical practice. This is a prospective, multi-center, observational patient registry. Adult outpatients who have pain due to a non-cancerous condition meeting study eligibility will be enrolled. Prescribers will treat patients according to their usual practice. Prescribers will treat patients, meeting study eligibility, with OXYRX according to their usual practice.

Study Type

Observational

Enrollment (Actual)

827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for treatment of a painful condition with a Schedule II opioid at an outpatient setting will be potential candidates for enrollment for this registry.

Description

Inclusion Criteria:

  • Pain requiring treatment with a Schedule II immediate release opioid within 3 days following the baseline visit
  • and pain that warrants treatment with a prescription for OXYRX PRN (alone or in combination) for at least 5 days after the baseline visit

Exclusion Criteria:

  • Use of any Schedule II opioid within 30 days prior to informed consent
  • planned use of other opioids (Schedule II-V) while using OXYRX
  • malignancy other than superficial skin cancers (ie, basal cell, squamous cell) within the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
oxycodone immediate release (OXYRX) Characteristics of pts. receiving prescription medications containing OXYRX
Drug: oxycodone immediate release (OXYRX)
Characteristics of pts. receiving prescription medications containing OXYRX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Describe clinical / demographic characteristics of patients receiving OXYRX; characterize patient / prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment; describe prescriber decision-making about pain meds
Time Frame: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28
Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ortho-McNeil Janssen Scientific Affairs, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (Estimate)

September 16, 2009

Study Record Updates

Last Update Posted (Estimate)

April 2, 2010

Last Update Submitted That Met QC Criteria

April 1, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR015670

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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